HIFLO ENDO-High Flow Nasal Cannula in GI Endoscopy

NCT ID: NCT03028688

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-21
• Study Completion Date: 2019-05-09

Brief Summary

Millions of patients undergo upper GI endoscopy in the United States each year. A large number of these patients have anesthesia to assist with their comfort during the procedure. The majority of patients do not have a protected airway during the procedure, meaning there is no endotracheal tube. Instead the current standard of care is to give supplementary oxygen via nasal cannula. Because patients are deeply sedated or have general anesthesia there is a risk for low oxygen saturation during the procedure, which presents a significant patient safety issue. The purpose of the clinical trial is compare the current anesthesia standard of care against high flow nasal cannula oxygen delivery during anesthesia. The investigator's hypothesis is that high flow nasal cannula oxygen delivery will decrease the frequency with which patients experience hypoxemia during anesthesia for upper GI endoscopy.

Conditions

Anesthesia Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Current standard of care

Participants in the current standard of care will receive the usual anesthesia care for upper GI endoscopy. In addition participants will have transcutaneous PCO2 measurements performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

High flow nasal cannula group

Participants in the high flow nasal cannula group will receive high flow nasal cannula oxygen and will also have transcutaneous PCO2 measurements performed.

Group Type: EXPERIMENTAL

High flow nasal cannula oxygen

Intervention Type: DEVICE

Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.

Interventions

High flow nasal cannula oxygen

Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Having Upper GI endoscopy expected to last greater than 15 minutes with anesthesia.

2. Age greater than or equal to 18 years

Exclusion Criteria

1. Propofol, midazolam, or fentanyl allergy

2. Pre-procedure plan for general anesthesia with an endotracheal tube (at the discretion of the attending anesthesiologist)

3. Any procedure with planned electro-cautery as a high-inspired oxygen concentration could increase the risk for airway or esophageal fire.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anesthesia Patient Safety Foundation

OTHER

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Michael Mazzeffi

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A Mazzeffi, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Countries

United States

References

Mazzeffi MA, Petrick KM, Magder L, Greenwald BD, Darwin P, Goldberg EM, Bigeleisen P, Chow JH, Anders M, Boyd CM, Kaplowitz JS, Sun K, Terrin M, Rock P. High-Flow Nasal Cannula Oxygen in Patients Having Anesthesia for Advanced Esophagogastroduodenoscopy: HIFLOW-ENDO, a Randomized Clinical Trial. Anesth Analg. 2021 Mar 1;132(3):743-751. doi: 10.1213/ANE.0000000000004837.

Reference Type: DERIVED

PMID: 32398433 (View on PubMed)

Other Identifiers

HP-00071111

Identifier Type: -

Identifier Source: org_study_id